MHRA Consultation: Amending the Human Medicines Regulations 2012
Survey ends: 27 September 2023
The MHRA is seeking your views on a 4-week long public consultation on amending the Human Medicines Regulations 2012.
The MHRA is proposing to amend the Human Medicines Regulations 2012 to remove the power for the Government to rely on the decision of the European Commission (EC) when approving a medicine for the Great Britain market.
As the United Kingdom (UK) exited the European Union, the MHRA introduced a mechanism that allowed it to rely on EC decisions when considering application for a UK marketing authorisation to authorise medicinal products. This procedure, known as the European Commission Decision Reliance Procedure (ECDRP), is due to come to an end on 31 December 2023.
The ECDRP will be replaced with the new international recognition framework. While the new international recognition framework will replace the ECDRP, it is outside the scope of this consultation.
The Government Body welcomes the views of patients, pharmaceutical and biotechnology researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public to help shape our approach to ending ECDRP.
The consultation will close on Wednesday, 27 September 2023.
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